BioNTech, Pfizer, Moderna and CureVac in major COVID-19 vaccine patent

battle
It was only a matter of time before the patents for coronavirus vaccines became the subject
of litigation. In summer 2022, the first infringement claims by CureVac in Germany hit the
news, followed by further disputes, also involving Moderna, in the US, UK and the
Netherlands.

CureVac started the dispute by filing a claim against BioNTech at the Regional Court
Düsseldorf for infringing one European patent and three German utility models with its
mRNA vaccine, Comirnaty. CureVac’s basic patent EP 18 57 122 B1, which the European
Patent Office granted in 2010, protects a process that improves the expression of mRNA in
cells.

Pfizer, BioNTech’s partner in the US, reacted with a counterclaim at the District Court of
Massachusetts to ascertain that its mRNA vaccine against COVID-19 does not infringe
CureVac’s US patents. In September 2022, BioNTech and Pfizer began an action against
CureVac and Moderna at the High Court of England and Wales.

Meanwhile, Moderna had sued BioNTech and Pfizer in Germany and the US for
infringement of its mRNA patents. At the Regional Court Düsseldorf, the claimant strives to
assert two patents, EP 35 90 949 and EP 37 18 565.

In each of the infringement claims, the respective claimants demand damages rather than a
withdrawal of the competing vaccines from the market. In the new year, further litigation
between the parties are expected to start in numerous jurisdictions. Revocation claims
against mRNA patents at European courts as well as oppositions at the EPO are currently
pending.
Bayer Corporation v. Union of India, 162 (2009) DLT 371

Facts

In 2008, Bayer Corporation (Plaintiff), was granted a patent by the Indian Patent Office
for its drug ‘Sorafenib Tosylate’ which is used to treat liver and kidney cancer.
Subsequently, in 2012, Natco Pharma was granted the first ever Compulsory License by
the Drug Controller of India (Defendants) to produce a generic version of this drug.
Plaintiff was selling the drug at Rs. 2,80,000 per month for a course and Defendant
promised to make this drug available for Rs. 8,800 only.
Plaintiff aggrieved by the fact that a Compulsory License had been granted to Natco and
moved to the Intellectual Property Appellate Board (IPAB) for a stay on the License
stating that the License granted by the DGCI was invalid, illegal and unsustainable.
However, the IPAB rejected Plaintiff’s appeal holding that the License was granted in
public interest because of its lower prices allowing people to access it.
Plaintiff then challenged the order in Bombay High Court (HC).

Issues

The case involved many allied issues, however, the main issue relating to patent infringement
were:

Whether the License granted by the DGCI was in accordance with the provisions of the
Patent Act?

Decision

The HC again dismissed the petition upholding that public interest shall always be
prioritised. It held that the objective behind the incorporation of the Patent Act is to
promote invention and safeguard the creator from infringement.
The HC held that interpreting Section 156 of the Patent Act, which gives the Central
Govt. the power to make rules, to say that DCGI cannot allow the sale of a drug patent
by someone else would be incorrect.
It held that DGCI could reasonably allow the commercialisation of generic drugs even if
they already patented in public interest as per Section 90 of the Patents Act. It clarified
that by doing so, DGCI would not be supporting or committing patent infringement
but on the contrary is responsible to avoid infringement since it has proper licenses in
place.
 It also held that the acceptance of the generic drugs would not amount to patent
infringement.

Novartis vs. Cipla, 2015

Facts

Novartis (Plaintiff) sued Cipla (Defendabt) for infringing patents covering Onbrez
(Indacaterol-drug used to treat chronic obstructive pulmonary disease) and sought
damages.
The drug is protected by 5 patents in India consisting of product composition and process
patents.
In 2014, the Defendant launched a generic version of Onbrez and in the process
petitioned to have the Plaintiff’s patents revoked. It contended that the disease has
reached an ‘epidemic’ stage and the monopoly of the Plaintiff was limiting the extent
of the drug.
In light of that requested the Central Government to revoke the patent under Section 92
(3) (compulsory license under special circumstances) and Section 66 (patents which
are prejudicial to public) of the Patents Act.
Defendant contended that the Plaintiff was not manufacturing the drug locally and
imported only limited quantities through a licensee.
Plaintiff then filed a case before the Delhi HC claiming patent infringement and
damages.

Court Decision

Delhi High court barred the Defendant from making or selling generic copy of the
Plaintiffs drug by granting temporary injunction to the Plaintiff.
The HC observed that Plaintiff had a strong prima facie case and as the validity of the
patent is not seriously questioned, there is a clear way out to grant injunction.
Defendant had previously also stated that there was a shortage of the drug and
inadequacy thereof. However, the HC observed that the Defendant failed to provide
any proof or figures for such claims.
In 2017, Cipla filed an appeal against this order. However, the appeal was dismissed on similar
grounds. The 2017 Appeal further divided into the implications of a drug being imported and
whether the extent of imports was sufficient to meet the demands in India.
Ericsson v Xiaomi, 2016

Facts

In December 2014, Ericsson (Plaintiff) had filed a suit against Xiaomi (Defendant) in
India for the alleged infringement of the 8 standard-essential patents (SEPs). A patent
that protects technology essential to a standard is called SEP. These SEPs are
indispensable while manufacturing standard-compliant products such as smart-phones
or tablets. Patents that are considered essential to execute a specific industry standard
cannot be exploited like any other patent, and certainly not to the elimination of other
market participants.
ThePlaintiff contended that the licenses on the SEPs were offered to be granted to some
companies on fair, reasonable and non-discriminatory (FRAND) terms, however, these
companies had refused to undertake such licenses and were using these patents without
license and accordingly were infringing Plaintiff’s SEPs.
The Delhi High Court granted an ex-parte injunction on the sale, manufacture, advertisement,
and import of Defendant’s devices. However, the Defendant claimed that its latest devices in the
Indian market (as of December 2014), contained chipsets, which implemented technologies
appropriately licensed by Plaintiff.

The Defendant subsequently challenged the injunction before a Division Bench of the Delhi HC.
The Defendant was temporarily permitted to resume the sale, import, manufacture, and
advertisement of its mobile devices subject to certain conditions like- It would only sell devices
having the licensed chips and such sale would not amount to infringement as per Section 107 of
the Patents Act. The court held that the Plaintiff had purposely withheld the fact about this
License and has failed to show a prima facie case.

In the span of two years, Ericsson had sued various companies like Micromax, Intex and Xiaomi
for the same issue. Micromax and Intex had approached the CCI. However, the investigative
order passed by the CCI suffered a major blow because Delhi HC held that it conflicted with its
jurisdiction.

The case highlights how patent holders use the law to sometimes extract large sums of royalties
and license fees for use of their technologies.

Vringo Infrastructure Inc. & Anr. v. Indiamart Indermesh Ltd. & Ors.

Facts
 Vringo Incorporation (Plaintiff), owned a large portfolio of patents in India. One such
patent held by the Plaintiff was ‘a method and a device for making a handover decision
in a mobile communication system’ which they had acquired from Nokia in 2012.
The Plaintiff approached the Delhi HC to grant an ad interim injunction against Indiamart
alleging the infringement of this particular patent.
Indiamart was the distributor for ZTE Corporation and ZTE Telecom India who were
involved in the business of manufacturing and selling mobiles, handsets, dongles etc.
(Defendants).
In 2014, the Plaintiff was granted an ad interim injunction against the Defendants by the
HC. However, it was later discovered that the injunction so passed was not confirmed.

Issues

Since the Patent Act does not presume the validity of the patent, the burden of proof to
prove that the Defendant has infringed upon the Plaintiff’s patent, rested on the
Plaintiff. The Plaintiff was not able to satisfy the court with a prima facie case of
infringement.
Whether a foreign company who has registered patents in India, but has not put the
patents to use can seek injunctions against others from using/ registering that patent?
Whether the plaintiff suffered an irreparable loss in this case?

Court Decision

With regards to the first issue, the Delhi HC held that the Plaintiff was not able to satisfy
the court with a prima facie case of infringement because the ‘expert’ opinion provided
by the Plaintiff was not considered to be so. It held that in cases of patent infringement
the expert opinion should be given by someone with expertise in that particular field.
In this case, the expert held a management degree and the nature of his work was
general in nature and could not be considered relevant under Section 21 of the
Evidence Act.
The patent in question was granted to Nokia in 2002 and was acquired by the Paintiff
only in 2006. The court held that this means Nokia was aware of the infringement and
chose not to take any action even before the assignment of the patent. It further upheld
the decision of Franz Xaver Huemer vs. New Yash Engineers AIR 1997 Delhi 79,
wherein it was decided that if a patent is registered in India by a foreigner but not used,
then others cannot be restrained from using/ registering that patent as it would
seriously affect the economy. The Plaintiff had only licensed the patent to other
companies, and these licensees did not file for infringement. Thus, the court held that
in this case an injunction would cause unnecessary damage to the Defendants.
The Court finally held that the Plaintiff had not suffered an irreparable loss as their loss
could be easily calculated in monetary terms and adequately compensated.
 Thus, considering the above-mentioned factors, the court vacated the injunction but
appointed experts to assist the court in determining infringement of the patent.

Aloys Wobben vs Enercon (India) Limited on 8 September, 2010

Facts

Dr. Aloys Wobben (Plaintiff) held several Indian Patents in this field.
In 1994, Enercon India (Defendant) was carrying out manufacturing operations as agreed
in a joint venture agreement. However, the agreement was eventually terminated and
the Defendant filed 19 revocation applications before the IPAB, seeking revocation of
Plaintiffs Indian Patents.
In retaliation, Plaintiff filed ten patent infringement cases before the Delhi HC against the
company and the Defendant added 4 more patents to the revocation list, taking the
total number of revocation petitions to 23 and in addition to that also filed a
counterclaim to the infringement suit.
In 2009, the Parties consented to an expedited trial for the infringement suit before the
Delhi HC, however, IPAB revoked 6 patents granted to the Plaintiff.

Issues

Whether, in a patent infringement suit and patent validity challenge, and a counter claim
from the Defendant thereof before the HC, the HC or IPAB will have exclusive
jurisdiction to decide the validity?
Whether, both, a counter claim as well as validity of patent can be examined
simultaneously, as per Section 64(I) of the Patents Act?

Supreme Court Decision

Upon examination of Section 25 (2) and 64 (I) of the Act, the SC examined that “any
person interested” can file a post- grant opposition and counter claim. It held that
Section 64 however, was subservient to the provisions of the Act wherever there is a
conflict and stated that both Section 25 (2) for post- grant opposition and 64 (I) for
counter claim cannot be applied simultaneously.
The SC held that if a revocation has been filed before the IPAB first then the Defendant
in a patent infringement suit cannot file a counterclaim on the same cause of action.
Lastly, the SC held that, since both Parties have consented to an expedited trial for the
infringement suit before the Delhi HC, it would not be open to either of the consenting
parties, to seek redressal from another forum. Thus, the Defendant will have to pursue
 the infringement suit and the counterclaim before the Delhi HC and not the revocation
before IPAB.

Merck Sharpe and Dohme Corporation v. Glenmark

Facts

Merck Sharpe and Dohme Corporation (Plaintiff) obtained a patent for antidiabetic drugs
and called them “Januvia” (sitagliptin) and “Janumet” (combination of sitagliptin and
metformin) in 2007. The Plaintiff launched “Januvia” in India only for Rs. 43 (1/5th of
its price in the USA) in public interest. In addition to that they also launched a patient
access program for the same.
The Plaintiff had a basic patent for Sitagliptin and its acceptable salts and additionally
had a patent application pending for Sitagliptin Phosphate Monohydrate (the
compound used in the defendants’ products), which was abandoned.
Glenmark (Defendant), started making and marketing generic versions of these two drugs
under the brand “ZITA” and “ZITA –MET”, respectively, leading the Plaintiff to file
an infringement suit against the Defendant.
Initially,
the Plaintiff was refused an interim injunction against but this was subsequently
reversed by the Delhi HC granting the injunction. This order was then challenged in
the SC by the Defendant.
Glenmark filed a statement plus counterclaim seeking revocation for Plaintiff’s patent on the
basis that:

The patent lacked an invention/ inventive step and the invention in the suit patent was
obvious to a person skilled in the art.
The invention lacked industrial applicability.
Patent was obtained on a false suggestion or representation.
There was insufficient disclosure pertaining to the preparation of Sitaglintin.
Plaintiffhad not disclosed the fact that they had abandoned their subsequent patent
application in India.
They claimed that it did not amount to infringement because Defendant’s product contained a
different chemical entity- Sitagliptin Phosphate Monohydrate having different physical and
chemical properties than Plaintiffs patent and that the generic drugs “ZITA” and “ZITA-MET”
are beneficial to the public at large because of their low cost.

Supreme Court Decision:

The court noted that the onus to prove that the invention in the patent was obvious would
rest on the Defendant. The court placed emphasis on the definition of ‘invention’ given
in Section 2(1) (ac) of the Patent Act and according to which “invention” is a new
 product or process involving an inventive step and capable of industrial application,
which was applicable in this case.
Further,
the court found that the Defendant’s product containing Sitagliptin Phosphate
Monohydrate was directly covered by Plaintiffs basic patent.
The court thus restrained Defendant with a decree of permanent injunction from making,
using, selling, distributing, advertising, exporting, offering for sale or dealing in
Sitagliptin Phosphate Monohydrate or any other salt of Sitagliptin in any form, alone
or in combination with any other drug.
With reference to revocation of the patent, the court stated that it is not mandatory for the
court to revoke the patent merely because any of the grounds mentioned in Section
64(1) are made out. The Section uses the word ‘may’ which confers discretionary
powers on the court to revoke a patent. However, no damages were awarded.

Ravi Kamal Bali v. Kala Tech. and Ors

Facts

Ravi Kamal Bali (Plaintiff) had been granted a patent in lieu of ‘tamper locks/ seals’ in
1994. He had also secured an additional patent for an improvement on the tamper lock,
called ‘TechLock’.
Afteran investigation, Plaintiff found that the Defendants (three defendants) were using
and selling similar products and filed a patent infringement suit before Bombay HC.
The Plaintiff came across a similar product bearing the name “SEAL TECH” which had
constructional and functional features similar to that of the Plaintiff’s TechLock.
The Plaintiff accordingly sought for an injunction restraining the Defendants from
making of, using, selling or distributing tamper proof locks/ seals.
While the Plaintiff suggested that the Defendants product was similar to his patented
product, the Defendant claimed that Seal Tech was not identical to TechLock in look
or function citing proof of the amount of pressure required to operate the lock.
The Plaintiff pleaded the Doctrine of Equivalents according to which, it is not necessary
that goods have to be identical to one another in order to consider it infringement.

Issue

Whether the Defendant’s product Seal Tech infringes upon the Plaintiffs product Tech
Lock in light of the Doctrine of Equivalents.

Court’s Decision
 The Court decided in favor of the Plaintiff and applied the Doctrine of Equivalents. The
Court held that the two products in comparison had the same purpose, made of the
same material and similar functions and stated that merely a different construction and
build of a product does not imply a new invention.
To determine this, the court applied Section 54 of the Patents Act, which states that only
the patentee is entitled to make improvements and modifications to a patented product
and claim patent for it. Which simply means that one cannot make small changes to an
already patented product and call it an invention.
The essence of the Doctrine of Equivalents is to preserve and protect the patented
product. However, the doctrine has been interpreted differently by various courts over
the years and its application in the Indian patent system is yet to be ascertained fully.

Shogun Organics Ltd v. Gaur Hari Guchhait

Facts

Shogun Organics Ltd. (Plaintiff) is a company engaged in the research, manufacture, and
sale of mosquito repellents and Manaksia Ltd. (Defendant) is a competitor of the
Plaintiff.
ThePlaintiff was granted a patent in 2009. The Defendant filed a post-grant opposition in
2013 which was considered by the IPAB, which reinstated the Plaintiffs patent.
The Plaintiff soon became aware that the Defendant had been using this patent
technology and brought an infringement suit against the Defendant. The Plaintiff
prayed the court to grant a permanent injunction and to restrain the Defendant from
using the patented technology.
The Plaintiff submitted that it has been granted registration under section 9(3) of the
Insecticides Act, 1968 in the year 1997 and that the Defendant’s registration was just a
follow up registration as it was granted under Section 9(4) in 2009.
The
defendant argued that the patented technology itself was invalid. The defendants
submitted that the patented process was disclosed earlier in the year 1997 through an
application made under the Insecticides Act, 1968, and is in public knowledge since
then.
However, the Plaintiff argued that they had a unique six-step synthesis process for producing D-
trans Allethrin. It did not deny the prior use argument but instead stated that the process
employed before for its production was totally different from the patented process.

Issues

Whether the registration under the Insecticides Act counts as prior publication or not
(including disclosure to government authorities).
Whether there the defendant had infringed the patented process.
Court Decision

The court had asked the Defendant repeatedly to submit the process used by the
Defendant. Under Section 104A of the Patents Act, the Court can ask the Defendant to
prove that the process used by the Defendant is different from the patented process.
However, they failed to submit the same.
The Court dismissed the prior use argument stating that although the Plaintiff was using
and selling D-trans Allethrin prior to the grant of patent but since nobody can ascertain
the process of manufacturing by mere examination of the product it does not amount to
prior/ public use.
Lastly, the court held that disclosure to the Government department or any authority
would not amount to prior use, according to Section 30 of the Patents Act.

Indoco Remedies Ltd v. Bristol Myers Squibb Holdings

This a very recent case before the Division Bench of the Delhi High Court (court), during the
prevailing COVID-19 pandemic situation.

Facts

Bristol Myers Squibb (Bristol) was the patent holder and producer of a drug called
“Apixaban”. Bristol approached Delhi HC in 2019 seeking an ad-interim injunction
against Indoco Remedies (Indoco) for infringing their patent and producing a generic
form of the drug called “APIXABID”.
In 2020, Indoco approached the court seeking permission to sell the already
manufactured (58,000) strips of the drug on grounds of ‘public interest’, especially
during the COVID 19 pandemic.
Indoco submitted that the drug was important for treating COVID 19 and was much
cheaper than Bristol Myers’ drug.
Bristol Myers argued that Indoco had only manufactured these strips in anticipation of
the injunction and the sale cannot be allowed due to clear infringement. They further
contended that in light of ‘public interest’ the appropriate remedy would be a
compulsory license.

Court Decision

However, Indoco’s request to sell the drug was denied by the court citing that there was
no evidence for shortage of the Bristol Myers drug to allow the sale of the generic drug
and also it did not prove any overwhelming public interest reason.
The court opined that in cases of patent infringement the court generally looks at three
parameters- prima facie case, balance of convenience and irreparable loss to the
 person seeking interim injunction. The Supreme Court, through many cases introduced
a fourth parameter i.e ‘public interest’, however, that does not mean that the courts do
not take into consideration the other three parameters. Even in the face of a pandemic,
the court held that it is necessary to see all three-four parameters in conjunction.

Conclusion
Patent infringement is a very common occurrence especially in the pharmaceutical industry.
Pharma companies are always on their toes with patent cases. However, the concept of patent
infringement grows and expands with every case. The ten cases mentioned above span over a
decade or so and highlight key cases which have shaped the understanding of patent
infringement right now. While in most cases, like Bayers vs Natco, the court held the public
interest is of utmost importance, in the last case of Bristol Myres and Indoco, the court held that
just because public interest is of utmost importance, it cannot be misused to escape patent
infringement.

A couple of cases mentioned above delve into the concept of the Doctrine of Equivalents. This
Doctrine, though used in Indian cases, has a very varied approach and its stance is not yet clear.
Court uses it and interprets it in different ways.

Overall, patent infringement is a very important aspect for many industries especially pharma
and technology companies. Courts generally decide patent infringement on the basis of three
parameters- prima facie case, balance of convenience and irreparable loss to the person seeking
interim injunction and public interest the foruth parameter. The cases above show us how patent
infringement is interpreted amongst these four parameters and deal with various issues like direct
infringement, injunctions, clash of jurisdictions etc.

BAJAJ Auto Limited Vs. TVS Motor Company Limited JT 2009 (12) SC 103
This case has two aspects, one related to patent infringement and the other related to the speedy
disposal of intellectual property rights cases.

The case involved the unauthorized application and use of the patented Digital Twin Spark
Ignition (DTSi) technology by TVS Motor Company (Defendant). The DTSi was the intellectual
property of BAJAJ auto limited (Plaintiff). Plaintiff had applied for a patent application for the
technology in the year 2002 and was granted a patent in 2005.

Facts

In 2007, Plaintiff filed a case before the Madras High Court against Defendant for
infringement of the patent and sought a permanent injunction for the same under
Section 108 of the Act. The Plaintiff also filed for a temporary injunction while the
suit for permanent injunction was pending in the HC.
 Simultaneously,a second suit was filed by Defendant under Section 106, claiming that
the infringement claim filed by the Plaintiff was baseless as they had made
improvements and changes to the patented article.
The HC granted the Plaintiff a temporary injunction and instructed Defendant that they
could execute pending orders but could not take any new orders for vehicles using this
technology.
However, the injunction was vacated after a plea from the Defendant which led Plaintiff
to file an appeal before the Supreme Court of India (SC).

Issues

Whether Defendant had actually infringed the patent even though it had in fact made
improvements and changes to the patented article.

Appeal to the SC

However, the SC did not look at the merits of the case. For the SC, the main issue was
that the legal battle had taken approximately 2 years over a temporary injunction.
Without looking at the merits of the case, the SC dismissed the appeal by stating that all
matters in relation with IPR infringements must be expeditiously decided by the trial
courts especially at the point of granting/ refusing injunctions.
The SC further directed the Madras HC to hear the case on a daily basis and dispose of on
or before 30th November 2009.

Final Judgement for the Patent Infringement

The Madras HC ultimately held that Plaintiff has the patent on the DTSi technology and
has been using it for five years.
The HC used the Doctrine of Equivalence and stated that, “It is also clear as per the
decisions, for the purpose of deciding the novel features to constitute “pith and
marrow” a purposive construction has to be given in order to make it essential
requirement of the invention that any variant would follow outside the monopoly even
if it could not have material effect upon the working of invention”