We are happy to bring to you a guest post by Mr. Sandeep K. Rathod. Sandeep is a lawyer with extensive experience in the pharmaceutical space. The views contained in this post are his personal and do not necessarily reflect the views of his current or past employer.
Some Trends in Pharmaceutical Patent Infringement Actions
Sandeep K. Rathod
Why has Pfizer filed a case against A. Gandhi and D. Rawal? Or why had Bayer IP sued Mr. Abhijeet or Roche sued SD Kaul? Are these names of new generic pharmaceutical companies infringing the IP of Pfizer or Sanofi?
In the last few years, we have seen a host of cases where pharmaceutical companies have filed lawsuits against individuals and which upon deeper checks reveal that these actually are patent infringement law suits against generic pharmaceutical companies!
The Patents Act, 1970 gives product patentee the exclusive right to prevent third parties, who do not have the patentee’s consent, from the act of making, using, offering for sale, selling or importing for those purposes that product in India. Patentee’s rights are enforceable by filing a civil suit for patent infringement. Patentees are trying to stop alleged and potential infringers by seeking interim injunctions.
How injunction requests filed are in pharmaceutical patent suits (defendant masking)?
A significant component of this plaint and ex-parte injunction filing trend is the masking of the identity of the lead corporate defendant from searchable Court databases. A large majority of these infringement suits being filed are not filed against the corporate entity / name of the generic company as the first defendant, rather these suits are filed against senior officers of company being made the first defendant. The other defendants (i.e. including the most important defendant – the actual generic company) is covered within the umbrella word ‘and another’ or is named as second or third defendant. The generic company’s name thus does not figure in the on-line, searchable ‘cause-lists’ that are released by the Court every evening and hence the company remains unaware of such ‘ex-parte’ suits filed against the Company and is therefore prevented from appearing in courts to prevent the ex-parte injunction hearings. A sample of such filings:
|Table for data on individuals being named as lead defendant|
|#||Plaintiff||Lead Defendant||Real defendant|
|1.||Teva Pharmaceutical Ind.||V. C. Nannapaneni||Natco Pharma|
|2.||Bristol-Myers Squibb Company||Mr. M. Adinarayan||Natco Pharma|
|3.||Astrazeneca AB||Mr. A. V. Reddy||Lee Pharma|
|4.||Bayer Intellectual Property||Mr. Abhijeet||Dr. Reddys Laboratories Mr. Abhijeet Mukherjee is the COO at Dr. Reddys|
|5.||F. Hoffmann-La Roche Ltd||S. D. Kaul||Intas PharmaThe named first defendant, who is an independent director at Intas was later removed from the cause title vide a Court Order.|
|6.||Pfizer Products Inc.||Mr. A. Gandhi||Sun Pharma Here too, the named first defendant was later removed from the cause title vide a Court Order|
|7.||Pfizer Products Inc.||Mr. D. Rawal||Cadila Healthcare|
|8.||Pfizer Products Inc.||Dr. Mody||Unichem Laboratories LimitedHere too, the named first defendant was later removed from the cause title vide a Court Order|
|9.||Wyeth LLC||Mr. Jayesh Choksi||Gufic Ltd.|
The Author wonders whether such unique order in arraying the defendants – where an individual is put as first defendant and the generic corporate entity is put as defendant 2 is an instance of inappropriate arraying of defendants as it is generic company and not the individual that would market the drug. The drug regulator does not grant approval to an officer of the generic company – the approval is given to the generic company and it is that same corporate entity which will make the generic product and sell it in the market.
What is the nature of injunction requests in pharmaceutical patent cases?
An overwhelming majority of injunction requests are filed as ex-parte and are quia-timet in nature. This means that the defendant generic company, in all likelihood, not aware of his being sued, will therefore not be able to present his defense before the issuance of the injunction on the first day and will be able to present his case only after an injunction has been issued against him.
Such filing with defendant’s directors or employees being targeted to secure grant of ex-parte injunctions in pharmaceutical patent cases is worrying since unlike a spurious / fake trademarked good’s seller who will hide his identity or may escape when given an advanced warning of injunction, an alleged pharmaceutical patent infringer can and will market his version of the drug, only after getting requisite approvals from the drug regulator and is required by law to place his product along with his address, price and other particulars clearly mentioned.
A detailed article discussing more of the above trends is available on SSRN here.
Image from here